ORALDENE

Active substance: HEXETIDINE

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LOT

EXP

100 ml
100 m

Medicated Relief for
Medicated Relief for
Mouth & Throat Infections
Hexetidine

F309417
13/0005

How to use this medicine

Possible side-effects

Check the table below to see how much medicine
to use.
Oraldene is for topical use only, which means that
it should not be swallowed or taken internally.

Oraldene can have side-effects, like all medicines, although
these don’t affect everyone and are usually mild.
If you experience the following, stop using the medicine
and talk to your doctor:
■ Swelling of the face, lips, mouth, tongue or throat
which may cause difficulty in swallowing or breathing
■ Allergic reactions including itchy rash ■ Irritation,
tingling or numbness of the tongue and/or tissues
inside the mouth ■ Shortness of breath ■ Cough ■ Dry
mouth ■ Feeling sick (nausea) ■ Sickness (vomiting)
■ Salivary gland enlargement ■ Taste disturbance or loss
of taste ■ Pain, swelling, redness or heat ■ Tongue or
tooth discolouration ■ Blistering or ulceration
If you get any side effects, talk to your doctor, pharmacist
or nurse.

Hexetidine

i Children under 6 years old
Oraldene is not recommended for children under
6 years of age.

i Adults and Children aged 6 years and

Medicated Relief for
Mouth & Throat Infections

over

Age
Adults and
children
aged 6 years
and over

Dose
Rinse the mouth or gargle for
30 seconds with at least 15 ml
(approx. 1 tablespoonful) of
undiluted Oraldene two to three
times a day or as otherwise
directed.
■ Do not dilute.
■ Do not swallow.
■ Shake well before use.

If anyone accidentally swallows this
product
If anyone accidentally swallows this product,
contact a doctor or your nearest Accident
and Emergency department (Casualty) taking
this pack with you.

If you forget to use the medicine
Use the next dose as soon as you remember
unless it is time to use it again. Do not use
two quantities in one go.

oraldene

What the medicine is for
The mouthwash contains hexetidine, which is an
antibacterial and antifungal and is used to help
treat throat and mouth infections, including
mouth ulcers, thrush, sore or bleeding gums
(called gingivitis), bad breath (halitosis) or sore
throat. It can also be used before and after dental
surgery to help prevent infections.

Reporting of side-effects
If you get any side-effects, talk to your doctor, pharmacist
or nurse. This includes any possible side- effects not listed
in this leaflet. You can also report side-effects directly via
the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side-effects you can help provide more
information on the safety of this medicine.

Storing this medicine
Antibacterial
Mouthwash
to relieve

gingivitis
mouth ulcers
sore gums
sore throat

This carton was revised August 2013. ©
Oraldene is a registered trade mark.
Product Licence holder: McNeil Products Ltd,
Maidenhead, Berkshire, SL6 3UG, UK.
Manufacturer: Famar Orléans, 5 avenue de
Concyr, 45071 Orleans, Cedex 2, France.
PL 15513/0067
MA 100/00401

Hexetidine

Do not use if bottle seal is broken when purchased.
Do not store above 30°C.
Use within 6 months of opening.
Protect from light.
Keep in the outer container.
Keep out of the reach and sight of children.
Do not use your medicine after the date shown as an
expiry date on the packaging.
Retain carton for full instructions.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

Further information
What’s in this medicine?
The active ingredient is: Hexetidine 0.1 g/100 ml
Other ingredients are: Polysorbate 60, citric acid,
saccharin sodium, levomenthol, eucalyptus oil,
ethanol 96%, azorubin (E122) sodium calcium edetate,
sodium hydroxide (E524), and purified water.

What the medicine looks like

100 ml

Oraldene is a clear red solution available in 100 ml
and 200 ml bottles. It contains 0.1 g of the active
ingredient in every 100 ml of medicine.

Before using this medicine
This medicine is suitable for most people, but a
few people should not use it. If you are in any
doubt, talk to your doctor or pharmacist.

Do not use this medicine…
■ If

you have ever had a bad reaction to
Oraldene or any of its ingredients. If this
applies to you, get advice from your doctor
or pharmacist without using Oraldene.
■ If your symptoms persist talk to your doctor
or pharmacist.

If you are pregnant or breast-feeding
■ Ask

your doctor or pharmacist for advice
before using Oraldene if you are pregnant
or breast-feeding.

Some of the ingredients can cause
problems
■ Ethanol

(96%) may cause irritation or dry
skin if frequently applied to the skin.
■ Azorubin (E122) can cause allergic reactions,
including asthma. Reactions are more
common in people who are allergic to aspirin.
■ Sodium content: 0.016 g/100 ml.

Hexetidine

Medicated Relief for
Mouth & Throat
Infections

Antibacterial
Mouthwash to relieve

gingivitis mouth ulcers
sore gums sore throat

100 ml

Do not use if bottle seal is broken
when p
purchased.
Keep out of the reach and sight of
p
children.

F309418-13-0004

CONTENTS: The solution contains Hexetidine 0.1 g/100 ml.
Other ingredients: Polysorbate 60, citric acid, saccharin
sodium, levomenthol, eucalyptus oil, ethanol 96%,
azorubin (E122) sodium calcium edetate, sodium hydroxide
(E524), and purified water.
Sodium content: 0.016 g/100 ml.
Oraldene has an antibacterial and antifungal action which
relieves mouth and throat infections, including:
mouth ulcers • sore and bleeding gums
• symptoms of sore throats • bad breath
Oraldene can also be used before and after dental surgery.
Read and retain carton for full instructions.
Oraldene is a registered trade mark.
PL holder: McNeil Products Ltd, Maidenhead,
Berkshire, SL6 3UG, UK.
PL 15513/0067 MA 100/00401

DIRECTIONS: Mouthwash for topical use only. DO NOT
SWALLOW. SHAKE WELL BEFORE USE.
ADULTS AND CHILDREN 6 YEARS AND OLDER
Rinse the mouth or gargle for 30 seconds with at least 15 ml
(approx. 1 tablespoonful) of undiluted Oraldene two to three times
a day. CHILDREN UNDER 6 YEARS - not recommended.
If symptoms persist discontinue treatment and consult your doctor
or dentist.
• Do not dilute.
• Do not store above 30°C.
Use within 6 months
of opening.
Protect from light. LOT
Keep container in
the outer carton. EXP

Minimum font size

LOT

EXP

200 m
ml

Medicated Relief for
Medicated Relief for
Mouth & Throat Infections
Mouth & Throat Infections
Hexetidine

F309419
13/0007

How to use this medicine

Possible side-effects

Check the table below to see how much medicine
to use.
Oraldene is for topical use only, which means that
it should not be swallowed or taken internally.

Oraldene can have side-effects, like all medicines,
although these don’t affect everyone and are usually mild.
If you experience the following, stop using the
medicine and talk to your doctor:
■ Swelling of the face, lips, mouth, tongue or throat
which may cause difficulty in swallowing or breathing
■ Allergic reactions including itchy rash ■ Irritation,
tingling or numbness of the tongue and/or tissues
inside the mouth ■ Shortness of breath ■ Cough ■ Dry
mouth ■ Feeling sick (nausea) ■ Sickness (vomiting) ■
Salivary gland enlargement ■ Taste disturbance or loss
of taste ■ Pain, swelling, redness or heat ■ Tongue or
tooth discolouration ■ Blistering or ulceration
If you get any side effects, talk to your doctor,
pharmacist or nurse.

Hexetidine

i Children under 6 years old
Oraldene is not recommended for children under 6
years of age.

i Adults and Children aged 6 years and

Medicated Relief for
Mouth & Throat Infections

over

Age

Dose

Adults and
children
aged 6 years
and over

Rinse the mouth or gargle for
30 seconds with at least 15 ml
(approx. 1 tablespoonful) of
undiluted Oraldene two to three
times a day or as otherwise directed.

If you get any side-effects, talk to your doctor,
pharmacist or nurse. This includes any possible sideeffects not listed in this leaflet. You can also report
side-effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side-effects you can help provide more
information on the safety of this medicine.

Do not dilute.
Do not swallow.
■ Shake well before use.


Storing this medicine

product

If anyone accidentally swallows this product,
contact a doctor or your nearest Accident and
Emergency department (Casualty) taking this
pack with you.

! If you forget to use the medicine
Use the next dose as soon as you remember
unless it is time to use it again. Do not use two
quantities in one go.
This carton was revised August 2013. ©
Oraldene is a registered trade mark.

Antibacterial
Mouthwash
to relieve

gingivitis
mouth ulcers
sore gums
sore throat

Do not use if bottle seal is broken when purchased.
Do not store above 30°C.
Use within 6 months of opening.
Protect from light.
Keep in the outer container.
Keep out of the reach and sight of children.
Do not use your medicine after the date shown as an
expiry date on the packaging.
Retain carton for full instructions.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose
of medicines no longer required. These measures will
help to protect the environment.

Further information
What’s in this medicine?

The active ingredient is: Hexetidine 0.1 g/100 ml
Other ingredients are: Polysorbate 60, citric acid,
saccharin sodium, levomenthol, eucalyptus oil, ethanol
96%, azorubin (E122) sodium calcium edetate, sodium
hydroxide (E524), and purified water.

Product Licence holder: McNeil Products Ltd,
Maidenhead, Berkshire, SL6 3UG, UK.
Manufacturer: Famar Orléans, 5 avenue de Concyr,
45071 Orleans, Cedex 2, France.

What the medicine looks like
PL 15513/0067
MA 100/00401

oraldene

What the medicine is for
The mouthwash contains hexetidine, which is an
antibacterial and antifungal and is used to help
treat throat and mouth infections, including
mouth ulcers, thrush, sore or bleeding gums
(called gingivitis), bad breath (halitosis) or sore
throat. It can also be used before and after dental
surgery to help prevent infections.

Reporting of side-effects



! If anyone accidentally swallows this

Hexetidine

200 m
ml

Oraldene is a clear red solution available in 100 ml and
200 ml bottles. It contains 0.1 g of the active ingredient
in every 100 ml of medicine.

Before using this medicine
This medicine is suitable for most people, but a
few people should not use it. If you are in any
doubt, talk to your doctor or pharmacist.

Do not use this medicine…
■ If

you have ever had a bad reaction to
Oraldene or any of its ingredients. If this
applies to you, get advice from your doctor
or pharmacist without using Oraldene.
■ If your symptoms persist talk to your doctor
or pharmacist.

If you are pregnant or breast-feeding
■ Ask

your doctor or pharmacist for advice
before using Oraldene if you are pregnant or
breast-feeding.

Some of the ingredients can cause
problems
■ Ethanol

(96%) may cause irritation or dry
skin if frequently applied to the skin.
■ Azorubin (E122) can cause allergic reactions,
including asthma. Reactions are more
common in people who are allergic to aspirin.
■ Sodium content: 0.016 g/100 ml.

PL 15513/0067
MA 100/00401

EXP

Medicated Relief for
Mouth & Throat
Infections

F309420-13/0006

Hexetidine

Do not use if bottle
seal is broken when
purchased.
Keep out of the
reach and sight of children.
DIRECTIONS: Mouthwash for
topical use only. DO NOT SWALLOW.
SHAKE WELL BEFORE USE.
ADULTS AND CHILDREN 6 YEARS
AND OLDER
Rinse the mouth or gargle for
30 seconds with at least 15 ml (approx.
1 tablespoonful) of undiluted Oraldene
two to three times a day. CHILDREN
UNDER 6 YEARS - not recommended.
If symptoms persist discontinue
treatment and consult your doctor or
dentist.
• Do not dilute.
• Do not store above 30°C.
Use within 6 months of opening.
Protect from light.
Keep container in the outer carton.

Antibacterial
Mouthwash to relieve

gingivitis mouth ulcers
sore gums sore throat

200 ml

LOT

CONTENTS: The solution contains Hexetidine
0.1g/100 ml. Other ingredients: Polysorbate 60,
citric acid, saccharin sodium, levomenthol,
eucalyptus oil, ethanol 96%, azorubin (E122)
sodium calcium edetate, sodium hydroxide (E524),
and purified water.
Sodium content: 0.016 g/100 ml.
Oraldene has an antibacterial and antifungal action
which relieves mouth and throat infections,
including: mouth ulcers • sore and bleeding
gums • symptoms of sore throats • bad breath
Oraldene can also be used before and after dental
surgery.
Read and retain carton for full instructions.
Oraldene is a registered trade mark.
PL holder: McNeil Products Ltd, Maidenhead,
Berkshire, SL6 3UG, UK.

Minimum font size

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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